Assembly for dispensing biomaterial, plunger therefor, and related methods

ABSTRACT

A plunger for use with a dispensing syringe to dispense a biomaterial is disclosed. The plunger includes a plunger body having a plunger head at its distal end and a plunger base at its proximal end. The plunger body defines a plunger passageway extending through the plunger body from the proximal end to the distal end. The plunger head is received within a syringe passageway of the dispensing syringe, and the plunger passageway receives a stylet.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. patent applicationSer. No. 14/202,720, filed Mar. 10, 2014, and published as U.S. PatentApp. Pub. No. 2014/0276581 on Sep. 18, 2014, which claims the benefit ofU.S. Provisional Patent App. No. 61/778,839, filed Mar. 13, 2013, thedisclosures of which are hereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention generally relates to dispensing equipment, andmore particularly to devices used for dispensing biomaterials such asbone graft materials.

BACKGROUND

Biomaterials are sometimes used in medical applications. For example,bone grafting is a surgical procedure for repairing bones and typicallyinvolves introducing a bone graft material (which is a type ofbiomaterial) into an area of bone that requires repair, such as afracture. The bone graft material is intended to stimulate growth ofhealthy native bone tissue, and new native bone tissue may eventuallyreplace the bone graft material completely. Bone graft materialtypically includes a combination of crushed bone and a liquid component,such as blood, plasma, or growth factors. Bone graft materials can beallograft (derived from a human other than the one receiving the graft),autograft (derived from the human receiving the graft), and synthetic(created from, for example, ceramics like calcium phosphates).

Bone graft materials are typically delivered to a surgical site usingsyringe-like delivery devices, which often include attachment devices,such as small diameter cannulus devices. In addition, the components ofthe bone graft material are sometimes brought together and combined toform the bone graft material in the delivery device. The bone graftmaterial is dispensed from the delivery device. This often involvesusing a syringe plunger to advance an amount of bone graft material froma syringe and through an attachment device, and then dispensing the bonegraft material from the attachment device at the surgical site. Once thesyringe plunger is completely depressed in the syringe, all or nearlyall of the bone graft material is expelled from the syringe. However,the attachment device still contains an amount of bone graft material,and further operation of the syringe plunger is ineffective foradvancing that bone graft material out of the attachment device. Thisprevents the bone graft material that is trapped in the attachmentdevice from being used during the surgical procedure, and leads towasting an amount of the bone graft material. Wasting bone graftmaterial is undesirable, however, as its components are costly. Inaddition, this drawback to current devices requires that more bone graftmaterial be prepared than is actually required at the surgical site, inorder to offset the amount that remains in the attachment device.

SUMMARY

According to one embodiment of the invention, an assembly is provided,and includes a dispensing syringe device and a cannulus device. Thedispensing syringe device is configured to receive an amount ofbiomaterial and to dispense the biomaterial. The dispensing syringedevice includes a syringe barrel for receiving the biomaterial, adischarge outlet for dispensing the biomaterial from the syringe barrel,and a plunger received in the syringe barrel. The plunger has a plungerbody and a plunger passageway extending therethrough configured toreceive a stylet. The cannulus device is configured to be coupled withthe dispensing syringe device, to receive biomaterial from thedispensing syringe device, and to dispense the biomaterial. The cannulusdevice includes a cannulus passageway configured to receive thebiomaterial and a dispensing opening configured for dispensing thebiomaterial.

According to another embodiment of the invention, a method is providedfor dispensing biomaterial. The method includes directing biomaterialfrom a dispensing syringe device into a passageway of a cannulus deviceusing a plunger. The method further includes engaging biomaterial in thepassageway of the cannulus device with a stylet, and directingbiomaterial out of a dispensing opening of the cannulus device using thestylet.

According to yet another embodiment of the invention, a plunger isprovided for use with a dispensing syringe device. The plunger includesa plunger body, a plunger head connected to the plunger body and sizedto correspond with the shape of a syringe passageway of the dispensingsyringe device, and a plunger passageway extending through the plungerbody and the plunger head. The plunger passageway is configured toreceive a stylet.

Various additional features and advantages of the invention will becomemore apparent to those of ordinary skill in the art upon review of thefollowing detailed description of the illustrative embodiments taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention and,together with a general description of the invention given above, andthe detailed description of the embodiments given below, serve toexplain the principles of the invention.

FIG. 1 is a perspective view showing an assembly constructed accordingto the concepts of the present invention and including a dispensingsyringe device and a cannulus device.

FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. 1.

FIGS. 3A-3C are cross-sectional views like FIG. 2, and showing bonegraft material being dispensed from the dispensing syringe device andthe cannulus device, and then a plunger plug being removed from theplunger of the dispensing syringe device.

FIG. 4 is a perspective view of an assembly like in FIG. 1 and showing astylet inserted into the plunger passageway of the plunger of thedispensing syringe device.

FIGS. 5A-5B are cross-sectional views taken along line 5-5 of FIG. 4 andshowing the stylet being inserted into the plunger passageway and thencontacting the bone graft material and directing it through the cannulusdevice.

FIG. 6 is a partial cross-sectional view showing the dispensing tip of acannulus device.

FIG. 7 is a disassembled perspective view showing components of anassembly according to another embodiment of the invention, and includinga dispensing syringe device and a cannulus device.

FIG. 8 is an assembled perspective view showing the assembly of FIG. 7.

FIG. 9A-9D are cross-sectional and sequential operational views takenalong line 9-9 of FIG. 8 and showing bone graft material being dispensedfrom the dispensing syringe device and the cannulus device, an extensionportion being coupled with a shaft portion to form a stylet, and thestylet being used to contact the bone graft material in the cannulusdevice and direct it through the cannulus device.

FIGS. 10A and 10B are cross-sectional and sequential operational viewsgenerally like FIGS. 9B and 9D, and showing an assembly according toanother embodiment of the invention.

FIG. 11 is a disassembled perspective view showing components of anassembly according to another embodiment of the invention, and includinga dispensing syringe device and a cannulus device.

FIG. 12 is a further disassembled perspective view of the assembly ofFIG. 11.

FIGS. 13A and 13B are cross-sectional and sequential operational viewsshowing bone graft material being dispensed from the dispensing syringedevice and the cannulus device.

FIG. 14A is an enlarged view showing the circled region of FIG. 13B, andshowing a rib on a plunger plug engaged with a groove on a plunger body.

FIG. 14B is an enlarged view like FIG. 14A, but showing the rib out ofengagement with the groove.

FIG. 14C is a cross-sectional view showing bone graft material beingfurther dispensed from the dispensing syringe device and the cannulusdevice after the rib is disengaged from the groove.

FIG. 15 is a disassembled perspective view showing components of theassembly of FIG. 11, but with an alternate cannulus device and analternate extension device.

FIGS. 16A-16D are partial cross-sectional views showing bone graftmaterial being dispensed from the dispensing syringe device and thecannulus device.

FIG. 17A is an enlarged view showing the circled region of FIG. 16C, andshowing a second finger ledge near a plunger base of a plunger.

FIG. 17B is an enlarged view like FIG. 17A, but showing the secondfinger ledge received in a socket of the plunger, and a shaft of anextension device being moved downwardly relative to the second fingerledge.

FIG. 17C is a cross-sectional view showing bone graft material beingfurther dispensed from the dispensing syringe device and the cannulusdevice after the second finger ledge reaches the plunger base.

FIG. 18 is a disassembled perspective view showing components of theassembly of FIG. 11 with a hydration device.

FIG. 19 is a cross-sectional view showing the hydration device coupledwith the syringe barrel such that a tubular member of the hydrationdevice is surrounded by bone graft material in the syringe barrel.

FIG. 20 is an enlarged view showing the circled region of FIG. 19, andshowing a fluid component moving from the tubular member into the bonegraft material, and air in the bone graft material escaping throughvents in a stopper element of a plunger plug.

DETAILED DESCRIPTION

Referring to the figures, and beginning with FIG. 1, an exemplaryassembly 10 is shown and includes a dispensing syringe device 12 and acannulus device 14. As will become apparent from the followingdescription, the assembly 10 is used to dispense biomaterial, such as toa surgical site. For example, in the embodiments shown and described,the biomaterial that is dispensed is a bone graft material, such as whatis used in a bone grafting procedure. The dispensing syringe device 12provides bone graft material to the reduced diameter cannulus device 14,and the bone graft material is dispensed from the cannulus device 14 tothe surgical site.

Referring first to FIGS. 1 and 2, the dispensing syringe device 12includes a syringe barrel 16 that has within it a syringe passageway 18.The syringe barrel 16 extends between a first end 20 and a second end22. The syringe barrel 16 includes a threaded locking tip 24 generallynear the second end 22. The threaded locking tip 24 is configured to becoupled with the cannulus device 14, as will be described below. Adischarge outlet 26 is defined in the syringe barrel 16 near the secondend 22.

The dispensing syringe device 12 also includes a plunger 28 that isreceived and moves in the syringe passageway 18. The plunger 28generally includes a plunger head 30 that is sized to correspond withthe shape of the syringe passageway 18. The plunger head 30 isconfigured for pushing bone graft material out of the syringe passageway18. A plunger body 32 is connected with the plunger head 30 and extendsalong the lengthwise direction of the syringe passageway 18. The plungerbody 32 is also connected with a plunger base 34 opposite the plungerhead 30.

As shown in FIG. 2, the plunger 28 also includes a plunger plug 36 thatis received in a plunger passageway 38. The plunger passageway 38 isgenerally centrally disposed in the plunger 28 and extends along thelengthwise direction of the plunger 28 between the plunger head 30 andthe plunger base 34. In particular, the plunger passageway 38 extendsthrough the plunger head 30, the plunger body 32, and the plunger base34. In the embodiment shown, the plunger plug 36 extends in the plungerpassageway 38 from the plunger head 30 to the plunger base 34. Theplunger plug 36 includes a plug flange 40 that rests on the plunger base34 when the plunger plug 36 is installed in the plunger 28.

As shown, the plunger head 30 has a generally cylindrical shape, and isdefined partly by the plunger body 32 and partly by the plunger plug 36when the plunger plug 36 is installed in the plunger 28. However, othershapes and configurations are also possible, such as a generallyfrusto-conically shaped plunger head, for example.

The cannulus device 14 is removably coupled to the dispensing syringedevice 12 at the second end 22 thereof. The cannulus device 14 has agenerally tubular body 42 and extends between a first end 44 and asecond end 46. The body 42 includes a threaded attachment cap 48 nearthe first end 44 and a dispensing tip 50 near the second end 46, whichincludes a dispensing opening 52. A cannulus passageway 54 extendsthrough the body 42 and communicates with the dispensing tip 50. Thecannulus passageway 54 has a generally reduced diameter as compared withthe syringe passageway 18.

The threaded attachment cap 48 is configured for connecting with thethreaded locking tip 24 of the syringe barrel 16 so as to create aremovable connection between the dispensing syringe device 12 and thecannulus device 14, as shown in the figures. In particular, the cannulusdevice 14 may be removed from the dispensing syringe device 12 in orderto place an amount of bone graft material into the syringe barrel 16 fora dispensing operation. The cannulus device 14 may be reattached to thedispensing syringe device 12 for dispensing the bone graft material.

Referring next to FIGS. 3A-3C, the assembly 10 is used for dispensingbone graft material 60 that has been introduced into the dispensingsyringe device 12. In particular, downward movement of the plunger 28directs the bone graft material 60 contained in the syringe passageway18 out of the syringe barrel 16 and into the cannulus passageway 54 ofthe cannulus device 14. Further downward movement of the plunger 28directs the bone graft material through the cannulus passageway 54, andout the dispensing opening 52.

However, movement of the plunger 28 is confined to the syringe barrel16, and so the plunger 28 is not effective for dispensing all of thebone graft material 60 from the assembly 10. Particularly, the plunger28 cannot dispense all of the bone graft material 60 in the cannulusdevice 14, as shown in FIG. 3B. After the plunger 28 has been pushed asfar as possible in the syringe barrel 16, all or nearly all of the bonegraft material 60 has been dispensed from the syringe barrel 16, asshown in FIG. 3B. However, an amount of the bone graft material 60remains in the cannulus device 14, as also shown in FIG. 3B.

To direct the bone graft material 60 out of the cannulus device 14, astylet 70 is used to engage and push the bone graft material 60 out ofthe cannulus device 14. In particular, the stylet 70 is inserted throughthe plunger passageway 38 and advanced toward the bone graft material 60in the cannulus device 14.

To make room for the stylet 70, the plunger plug 36 is removed from theplunger 28, as shown in FIG. 3C. In particular, the plunger plug 36 isremoved from the plunger passageway 38. For example, a user can graspthe plug flange 40 and move the plunger plug 36 away from the plunger28. Then, as shown in FIGS. 4 and 5A-5B, the stylet 70 is inserted intoand through the plunger passageway 38, and is used to direct the bonegraft material 60 out of the cannulus device 14.

The stylet 70 includes a main body portion or shaft 72 that is attachedto a handle 74. The shaft 72 is configured to fit and slidably movewithin the plunger passageway 38 of the plunger 28 and the cannuluspassageway 54 of the cannulus device 14. The shaft 72 includes a headportion or tip 76 that is generally opposite from the handle 74 and isgenerally sized to correspond with the internal shape of the cannuluspassageway 54. The tip 76 is configured for pushing bone graft material60 out of the cannulus passageway 54. The handle 74 provides a locationfor a user to grasp the stylet 70 and is generally ring-shaped, althoughother handle shapes are also possible. The stylet 70 is configured toengage the bone graft material 60 that is in the cannulus passageway 54and advance it toward and out of the dispensing opening 52.

While the cannulus passageway 54 shown in FIGS. 3A-3C and 5A-5B has agenerally straight profile near the dispensing opening 52, analternative configuration is shown in FIG. 6. FIG. 6 shows the cannuluspassageway 54 is defined by a taper region 80 which tapers radiallyinwardly near the dispensing opening 52. The taper region 80 forms astop for engaging with the tip 76 of the stylet 70, as shown, and forpreventing the tip 76 from reaching or exiting the dispensing opening52.

Referring next to FIGS. 7-9D, an assembly 110 is shown that generallyincludes a dispensing syringe device 112 and a cannulus device 114. Theassembly 110 is generally similar to the assembly 110, except as furtherdescribed below.

The dispensing syringe device 112 includes a syringe barrel 116 that haswithin it a syringe passageway 118. The dispensing syringe device 112includes a plunger 128 that is received and moves in the syringepassageway 118. The plunger 128 generally includes a plunger head 130that is sized to correspond with the shape of, and push bone graftmaterial out of, the syringe passageway 118. A plunger body 132 isconnected with the plunger head 130 and is also connected with a plungerbase 134 opposite the plunger head 130. The plunger 128 also includes agenerally centrally disposed plunger passageway 138 that extends throughthe plunger head 130, the plunger body 132, and the plunger base 134.

A plunger plug 136 is generally situated in the plunger passageway 138,and includes a shaft portion 131 and a cap portion 133 (FIGS. 7 and 9A).The cap portion 133 is configured to be removably coupled with the shaftportion 131 (FIG. 9C). The shaft portion 131 includes a socket 135 thatis configured to receive a stem 137 of the cap portion 133. In addition,the cap portion 133 includes a flange 140 that rests on the plunger base134 when the cap portion 133 is installed in the plunger 128, as shownin FIGS. 9A and 9B.

The plunger plug 136 includes structure for forming a threadedrelationship with the plunger body 132. In particular, the shaft portion131 includes a threaded portion 139 that is configured to be engagedwith a threaded portion 141 of the plunger body 132, as shown in FIGS.9A-9C. For example, in the embodiment shown, the threaded portion 139 ofthe shaft portion 131 is situated near a tip 143 of the shaft portion131, and the threaded portion 141 of the plunger body 132 is situatednear the region of the plunger head 130. When the threaded portions 139,141 are engaged (FIGS. 9A-9C), the shaft portion 131 is prevented frommoving in the lengthwise direction with respect to the plunger body 132.As shown, the plunger body 132 and the plunger plug 136 define agenerally frusto-conically shaped plunger head 130 when the plunger plug136 is installed in the plunger 128, but other shapes and configurationsare also possible, such as the generally cylindrical shape describedabove.

The shaft portion 131 is configured to be rotated with respect to theplunger body 132, such as to rotate the threaded portions 139, 141 intoand out of engagement with one another. To that end, the shaft portion131 includes structure for mating with an extension device 145, suchthat rotation of the extension device 145 causes rotation of the shaftportion 131. As best seen in FIG. 7, the socket 135 of the shaft portion131 includes lengthwise extending slots 147. The slots 147 areconfigured to receive and be engaged by nubs 149 on the extension device145.

The extension device 145 is configured to be removably coupled with theshaft portion 131. The extension device 145 generally includes a handle151 connected with a shaft 153 which terminates in a tip 155. In theembodiment shown, the nubs 149 extend radially outward from the shaft153 near the tip 155. The shaft 153 is sized to fit and slidably movewithin the plunger passageway 138 of the plunger body 132.

The extension device 145 is coupled with the shaft portion 131 byinserting the tip 155 of the extension device 145 into the socket 135 ofthe shaft portion 131, as shown in FIG. 9C. In particular, the nubs 149are aligned with the slots 147, and the tip 155 is pushed into thesocket 135. When the nubs 149 are thus positioned in the slots 147,rotation of the extension device 145 will cause rotation of the shaftportion 131, as indicated in FIG. 9C. In addition, downward movement ofthe extension device 145 will cause downward movement of the shaftportion 131.

The cannulus device 114 is removably coupled to the dispensing syringedevice 112. The cannulus device has a generally tubular body 142 havinga dispensing opening 152. A cannulus passageway 154 extends through thebody 142. The shaft portion 131 of the plunger plug 136, including thetip 143, is sized to fit and slidably move within the cannuluspassageway 154. In particular, the tip 143 is configured to push bonegraft material 160 out of the cannulus passageway 154.

The assembly 110 is used for dispensing bone graft material 160 that hasbeen introduced into the dispensing syringe device 112. In particular,downward movement of the plunger 128 directs the bone graft material 160contained in the syringe passageway 118 out of the syringe barrel 116and into the cannulus passageway 154 of the cannulus device 114. Furtherdownward movement of the plunger 128 directs the bone graft material 160through the cannulus passageway 154, and out the dispensing opening 152.During these steps, the shaft portion 131 is engaged with respect to theplunger body 132, and generally does not move with respect thereto. Inparticular, the threaded portion 139 of the shaft portion 131 is engagedwith the threaded portion 141 of the plunger body 132, as shown in FIGS.9A and 9B.

Movement of the plunger 128 is confined to the syringe barrel 116, andso the plunger 128 cannot dispense all of the bone graft material 160from the assembly 110. In a similar manner as described above, theplunger 128 cannot dispense all of the bone graft material 160 in thecannulus device 114. After the plunger 128 has been pushed as far aspossible in the syringe barrel 116, all or nearly all of the bone graftmaterial 160 has been dispensed from the syringe barrel 116, but anamount of the bone graft material 160 is still present in the cannulusdevice 114, as shown in FIG. 9B. The shaft portion 131 and the extensiondevice 145, which together form a stylet 157, are used to engage andpush the bone graft material 160 out of the cannulus device.

In particular, the cap portion 133 is removed from the shaft portion 131by removing them stem 137 of the cap portion 133 from the socket 135 ofthe shaft portion 131, as indicated in FIG. 9B. Then, the extensiondevice 145 is coupled with the shaft portion 131, as shown in FIG. 9C,to form the stylet 157. The stylet 157 is then rotated in order todisengage the threaded portions 139, 141 from each other. In particular,the extension device 145 is rotated so that the shaft portion 131 isrotated to cause the threaded portion 139 to be advanced away from thethreaded portion 141 of the plunger body 132 and toward the dispensingopening 152 of the cannulus device 114.

As shown in FIG. 9D, once the threaded portions 139, 141 are disengagedfrom each other, the stylet 157 can be used to direct the bone graftmaterial 160 out of the cannulus device 114. In particular, the tip 143of the shaft portion 131 engages the bone graft material 160 that is inthe cannulus passageway 154 and advances the bone graft material 160toward and out of the dispensing opening 152.

Referring next to FIGS. 10A and 10B, an assembly 210 is shown thatgenerally includes a dispensing syringe device 212 and a cannulus device214. The assembly 210 is generally similar to the assemblies 10 and 110,except as further described below.

The cannulus device 214 is substantially similar to the cannulus device114 described in association with FIGS. 7-9D. The dispensing syringedevice 212 is substantially similar to the dispensing syringe device 112described in association with FIGS. 7-9D, except with respect to theconstruction of the plunger body and the plunger plug. In FIGS. 10A and10B, a plunger body 232 and a plunger plug 236 do not include threadedportions like the threaded portions 141, 139 on the plunger body 132 andplunger plug 136. Rather, the plunger body 232 and the plunger plug 236have a generally smooth interface in the region of the plunger head 230.In particular, a shaft portion 231 of the plunger plug 236 includes asmooth-walled portion 239 generally near a tip 243 of the shaft portion231. A plunger body 232 includes a smooth-walled portion 241 near aplunger head 230. The respective smooth-walled portions 239, 241 allowthe shaft portion 231 to be easily moved away from the plunger body 232.

The assembly 210 can be used to dispense bone graft material 260 in amanner substantially similar to what is described above for assembly110, except that it is not necessary to rotate the plunger plug 236 todisengage it from the plunger body 232. In particular, the shaft portion231 of the plunger plug 236 can be combined with an extension device toform a stylet 257 that is used to advance the bone graft material 260out of the cannulus device 214.

Referring next to FIGS. 11-14C, an assembly 310 is shown that generallyincludes a dispensing syringe device 312 and a cannulus device 314. Theassembly 310 is generally similar to the assemblies 10, 110, and 210,except as further described below.

The dispensing syringe device 312 includes a syringe barrel 316 that haswithin it a syringe passageway 318. The dispensing syringe device 312includes a plunger 328 that is received and moves in the syringepassageway 318. The plunger 328 generally includes a plunger head 330that is sized to correspond with the shape of, and push bone graftmaterial out of, the syringe passageway 318. A plunger body 332 isconnected with the plunger head 330 and is also connected with a plungerbase 334 opposite the plunger head 330. The plunger 328 also includes agenerally centrally disposed plunger passageway 338 that extends throughthe plunger head 330, the plunger body 332, and the plunger base 334.

A plunger plug 336 is generally situated in the plunger passageway 338,and includes a shaft portion 331 and a stopper element 333, which in theembodiment shown is configured to be removably coupled with the shaftportion 331. In particular, the shaft portion 331 includes a first post331 a having a flared portion 331 b, and the stopper element 333includes a socket 333 a. When the stopper element 333 is coupled withthe shaft portion 331, the flared portion 331 b and the first post 331 aof the shaft portion 331 are received in the socket 333 a of the stopperelement 333. The stopper element 333 generally defines a tip 343 of theshaft portion 331 or the plunger plug 336, and may be formed of anelastomeric material, for example.

The plunger plug 336 includes structure for forming a snap-fitrelationship with the plunger body 332. In particular, the stopperelement 333 of the plunger plug 336 includes a rib 339 that extends froman exterior of the stopper element 333. In the embodiment shown, the rib339 extends around the entire circumference of the stopper element 333.Other configurations are also possible, wherein the rib 339 includes oneor more segments that do not extend around the entire circumference. Theplunger body 332 includes a groove 341 for receiving the rib 339. Inparticular, the groove 341 extends radially outward from the plungerpassageway 338 in the region of the plunger head 330. In the embodimentshown, the groove 341 is annular and extends entirely around the plungerpassageway 338 in order to receive the circumferential groove 341. Theplunger plug 336 “snaps” into engagement with the plunger body 332 whenthe rib 339 is received in the groove 341. The plunger plug 336 can bepushed out of engagement with the plunger body 332 by applyingsufficient force to move the rib 339 out of the groove 341. When the rib339 is engaged with the groove 341, the plunger plug 336 is preventedfrom moving in the lengthwise direction with respect to the plunger body332.

The plunger head 330 is partly formed by a plunger head stopper element337. In the embodiment shown, the plunger head stopper element 337 isconfigured to be removably coupled with the plunger body 332. Inparticular, the plunger body 332 includes a first attachment flange 328a and a second attachment flange 328 b. The plunger head stopper element337 includes a socket 337 a and an attachment band 337 b. When theplunger head stopper element 337 is coupled with the plunger body 332,the first attachment flange 328 a is received in the socket 337 a, andthe attachment band 337 b generally surrounds the plunger body 332between the first attachment flange 328 a and the second attachmentflange 328 b. The plunger passageway 338 extends through the plungerhead stopper element 337. The plunger head stopper element 337 includesan inclined wall 337 c, which extends at an angle of approximately 45°with respect to the plunger passageway 338. The plunger head stopperelement 337 may be formed of an elastomeric material, for example.

The plunger head 330 is also partly formed by the plunger plug 336 whenthe plunger plug 336 is installed in the plunger 328. Together theplunger head stopper element 337 and the plunger plug 336 define agenerally frusto-conically shaped plunger head 330, but other shapes andconfigurations are also possible, such as the generally cylindricalshape described above.

The shaft portion 331 includes structure for mating with an extensiondevice 345. In particular, the shaft portion 331 includes a second post335 having transversely extending nubs 335 a. The second post 335 ispositioned on the shaft portion 331 generally opposite from the firstpost 331 a. The extension device 345 is configured to be removablycoupled with the shaft portion 331, and includes a finger ledge 351connected with a shaft 353 which terminates in a tip 355. The fingerledge 351 provides a surface where a user can press on the extensiondevice 345. For example, a user can use one or more of his fingers, suchas his thumb, to press on the finger ledge 351 and move the extensiondevice 345. The shaft 353 and the tip 355 are sized to fit and slidablymove within the plunger passageway 338.

The tip 355 includes a generally tubular collar 349 that defines withinit a socket 350. The socket 350 is configured to receive the second post335 of the shaft portion 331. The collar 349 also includes channels 356that are configured to engage and receive the nubs 335 a on the secondpost 335. As shown, the channels 356 extend radially outward from thesocket 350, and follow a curved path upwardly from a leading edge of thetip 355.

The extension device 345 is coupled with the shaft portion 331 bydirecting the collar 349 over the second post 335 so that the secondpost 335 is received in the socket 350. The extension device 345 isrotated so the channels 356 of the collar 349 engage and receive thenubs 335 a. Once the extension device 345 is coupled with the shaftportion 331, downward movement of the extension device 345 will causedownward movement of the shaft portion 331.

The cannulus device 314 is removably coupled to the dispensing syringedevice 312. In particular, the cannulus device 314 includes anattachment portion 314 a that is configured to be coupled with thesyringe barrel 316 of the dispensing syringe device 312, such as byusing complementary threaded portions on the attachment portion 314 aand the syringe barrel 316. The attachment portion 314 a includes atapered or sloped wall portion 314 b. The sloped wall portion 314 b isinclined at an angle, such as to be generally complementary to theinclined wall 337 c of the plunger head stopper element 337, as shown inFIG. 14A. By using these complementary shapes between the plunger 328(the inclined wall 337 c of the plunger head stopper element 337) andthe cannulus device 314 (the sloped wall portion 314 b of the attachmentportion 314 a), the amount of bone graft material that is left in thesyringe barrel 316 can be minimized.

The cannulus device 314 also has a generally tubular body portion 342having a dispensing opening 352. The body portion 342 is configured tobe coupled with the attachment portion 314 a, such as by usingcomplementary threaded portions on the respective portions 342, 314 a,for example. A cannulus passageway 354 extends through the body portion342. The shaft portion 331 of the plunger plug 336, including the tip343, is sized to fit and slidably move within the cannulus passageway354. In particular, the tip 343 is configured to push bone graftmaterial 360 out of the cannulus passageway 354.

The assembly 310 is used for dispensing bone graft material 360 that hasbeen introduced into the dispensing syringe device 312. In particular,downward movement of the plunger 328 directs the bone graft material 360contained in the syringe passageway 318 out of the syringe barrel 316and into the cannulus passageway 354 of the cannulus device 314. Furtherdownward movement of the plunger 328 directs the bone graft material 360through the cannulus passageway 354, and out the dispensing opening 352.During these steps, the shaft portion 331 is engaged with respect to theplunger body 332, and generally does not move with respect thereto. Inparticular, the rib 339 is received in the groove 341, as shown in FIG.14A.

Movement of the plunger 328 is confined to the syringe barrel 316, andso the plunger 328 cannot dispense all of the bone graft material 360from the assembly 310. In a similar manner as described above, theplunger 328 cannot dispense all of the bone graft material 360 in thecannulus device 314. After the plunger 328 has been pushed as far aspossible in the syringe barrel 316, all or nearly all of the bone graftmaterial 360 has been dispensed from the syringe barrel 316, but anamount of the bone graft material 360 is still present in the cannulusdevice 314, as shown in FIG. 13B. The shaft portion 331 and theextension device 345, which together form a stylet 357, are used toengage and push the bone graft material 360 out of the cannulus device.The stylet 357 also includes the stopper element 333, which forms thetip 343 of the shaft portion 331.

In particular, the extension device 345 is coupled with the shaftportion 331, as shown in FIG. 13A, to form the stylet 357. The stylet357 is pushed downwardly in order to disengage the rib 339 from thegroove 341. In particular, the extension device 345 is pushed so thatthe shaft portion 331 is moved downwardly to cause the tip 343 to bemoved toward the dispensing opening 352.

As shown in FIGS. 14B and 14C, once the rib 339 and the groove 341 aredisengaged from each other, the stylet 357 can be used to direct thebone graft material 360 out of the cannulus device. In particular, thestylet 357 is moved downwardly and the tip 343 engages the bone graftmaterial 360 that is in the cannulus passageway 354 and advances thebone graft material 360 toward and out of the dispensing opening 352.

Referring next to FIGS. 15-17C, components of the assembly 310 areshown, except with an alternative cannulus device 400 and an alternativeextension device 402. In particular, the cannulus device 400 has a muchlonger tubular body portion 404 (FIG. 15) than the tubular body portion342 shown in FIGS. 11-14C.

Cannulus devices of different lengths may be used in differentapplications, for example. In situations where a long cannulus device isused, a generally correspondingly long stylet is required in order todirect bone graft material out of the entire length of the cannulusdevice. If a stylet is not sufficiently long, it will not be able todirect most or all of the bone graft material out of the cannulusdevice.

Because of the extended length of the body portion 404 of the cannulusdevice 400, the extension device 402 has a substantially longer shaft406 than the shaft 353 of the extension device 345 (compare FIGS. 12 and15). The extension device 402 includes a first finger ledge 408connected with the shaft 406 near an end thereof. The first finger ledge408 is generally similar to the finger ledge 351 described above, andprovides a surface where a user can press on the extension device 402.The extension device 402 also includes a second finger ledge 410, whichis useful because of the longer shaft 406. In particular, the secondfinger ledge 410 provides an additional surface where a user can presson the extension device 402.

The second finger ledge 410 is operatively associated with the shaft 406in a manner that allows the second finger ledge 410 to transfer downwardforce to the shaft 406, but also allows the shaft 406 to be moveddownwardly relative to the second finger ledge 410. In particular, theshaft 406 is allowed to move downwardly relative to the second fingerledge 410 once the second finger ledge 410 reaches the plunger base 334.To that end, the shaft 406 includes an indented region 412 that isgenerally medially-located along the length of the shaft 406. Theindented region 412 forms a shelf 414.

The second finger ledge 410 includes a hub 416 that supports aradially-extending ledge surface 418. The hub 416 generally surroundsthe shaft 406, and the ledge surface 418 provides a location where auser presses on the second finger ledge 410. The second finger ledge 410also includes longitudinally-extending legs 420. The legs 420 areflexibly coupled with the hub 416, and also generally surround the shaft406. The legs 420 are biased in a direction radially toward the shaft406, but can be flexed radially outward.

The legs 420 and the shelf 414 are configured for operatively couplingthe second finger ledge 410 with the shaft 406. In particular, the legs420 are biased radially inwardly and follow the shape of the indentedregion 412. The legs 420 can engage the shelf 414. When the legs 420engage the shelf 414, the second finger ledge 410 transfers downwardforce to the shaft 406, allowing a user to press on the ledge surface418 to move the shaft 406 downwardly (FIGS. 16A-16D).

As the length of the shaft 406 is moved into the plunger 328, the secondfinger ledge 410 approaches the plunger base 334 (FIG. 17A). The secondfinger ledge 410 does not impede further downward movement of the shaft406 when the second finger ledge 410 reaches the plunger base 334,however. When the second finger ledge 410 is moved to its downward-mostposition, a user presses on the first finger ledge 408, and the shaft406 continues its downward movement. In particular, when the userpresses on the first finger ledge 408 and the second finger ledge 410can no longer move, the shaft 406 moves downwardly relative to thesecond finger ledge 410 (FIG. 17B). The legs 420 of the second fingerledge 410 flex radially outward, following the shape of the indentedregion 412 of the shaft 406. The legs 420 flex further radially outwardand surround the shaft 406, but do not prevent the shaft 406 from movingfurther downwardly relative to the second finger ledge 410. Thereby, thefull length of the shaft 406 can be moved downwardly for directing thebone graft material 360 out of the cannulus device 400.

Optionally, the plunger 328 can include a socket 329 for receiving thesecond finger ledge 410, as shown. When the second finger ledge 410 isreceived in the socket 329, the ledge surface 418 is generally co-planarwith the plunger base 334 (FIG. 17B). The socket 329 is formed in theplunger body 332 and the plunger base 334. In a similar manner, theplunger 328 can include the socket 329 for receiving the finger ledge351 of the extension device 345.

The extension device 402 with two finger ledges is useful for one-handedoperation, such as where a user grips the syringe barrel 316 with hishand, and uses his thumb to operate the extension device 402. Inparticular, the user initially presses his thumb on the second fingerledge 410 to move the shaft 406 downwardly. When the second finger ledge410 reaches the plunger base 334, the user then presses his thumb on thefirst finger ledge 408 to further move the shaft downwardly. Thereby,the user can operate even an extended-length extension device, such asthe extension device 402, using only one hand.

Referring next to FIGS. 18-20, a hydration device 430 is shown that maybe used with any of the assemblies 10, 110, 210, and 310. In theembodiment shown, the hydration device 430 is shown in conjunction withcomponents of the assembly 310. The hydration device 430 is configuredto be removably coupled with the syringe barrel 316 in order to add afluid component to the bone graft material 360 contained in the syringebarrel 316. The hydration device 430 may include any of the structuresshown in Application Ser. No. 61/837,315, which is incorporated byreference herein in its entirety.

In the embodiment shown, the hydration device 430 includes a syringebarrel connector 432 and a main body portion 434. The syringe barrelconnector 432 is configured to be removably coupled with the syringebarrel 316, such as by using complementary threaded portions on thesyringe barrel connector 432 and the syringe barrel 316, for example.The syringe barrel connector 432 may be generally similar to theattachment portion 314 a of the cannulus device 314 described above. Themain body portion 434 is configured to be removably coupled with thesyringe barrel connector 432, such as by using complementary threadedportions on the main body portion 434 and the syringe barrel connector432, for example. The main body portion 434 is also configured to becoupled with a fluid component source via a fluid inlet 436.

The hydration device 430 includes a tubular member 438 which issupported by the main body portion 434. The tubular member 438 is influid communication with the fluid inlet 436 for receiving a fluidcomponent. The tubular member 438 includes a plurality of openings 440that are disposed along the length of the tubular member 438.

When the hydration device 430 is coupled with the syringe barrel 316,the tubular member 438 extends within the syringe barrel 316 in such amanner that the bone graft material 360 generally surrounds the tubularmember 438 (FIG. 19). A fluid component can be introduced through thefluid inlet 436 and into the tubular member 438. The fluid component canmove from the tubular member 438 through the openings 440, therebymoving into the bone graft material 360.

In order to accommodate the additional volume of the fluid component inthe syringe barrel, the plunger head 330 may include one or more ventsthat allow air in the bone graft material 360 to escape. In theembodiment shown, vents 333 b are provided in the stopper element 333.Thereby, when the fluid component moves into the bone graft material360, air displaced by the fluid component can escape through the vents333 b (FIG. 20).

Advantageously, the assemblies 10, 110, 210, and 310 can be used fordispensing other types of biomaterials than bone graft material. Inaddition, it will be appreciated that various of the features disclosedabove in association with certain of the assemblies 10, 110, 210, and310 might also be used with others of the assemblies 10, 110, 210, and310.

While the present invention has been illustrated by the description ofspecific embodiments thereof, and while the embodiments have beendescribed in considerable detail, it is not intended to restrict or inany way limit the scope of the appended claims to such detail. Thevarious features discussed herein may be used alone or in anycombination. Additional advantages and modifications will readily appearto those skilled in the art. The invention in its broader aspects istherefore not limited to the specific details, representative apparatusand methods and illustrative examples shown and described. Accordingly,departures may be made from such details without departing from thescope or spirit of the general inventive concept.

What is claimed is:
 1. A plunger for use with a dispensing syringeconfigured to dispense a biomaterial, the plunger comprising: a plungerbody having a plunger head at its distal end and a plunger base at itsproximal end, and defining a plunger passageway extending through theplunger body from the proximal end to the distal end, wherein: theplunger head is configured to be received within a syringe passageway ofthe dispensing syringe, and the plunger passageway is configured toreceive a stylet.
 2. The plunger of claim 1, further comprising aplunger plug configured to be removably coupled to the plunger body. 3.The plunger of claim 2, wherein the plunger passageway is configured toreceive the stylet following removal of the plunger plug from theplunger passageway.
 4. The plunger of claim 2, wherein the plunger plugincludes a shaft extending distally from a cap, the cap being receivedon the plunger base and the shaft being received within the plungerpassageway when the plunger plug is coupled to the plunger body.
 5. Theplunger of claim 4, wherein the cap is removably coupled with the shaft.6. The plunger of claim 5, wherein: the shaft defines a socket, the capincludes a stem, and the socket of the shaft is configured to receivethe stem of the cap to removably couple the cap to the shaft.
 7. Theplunger of claim 4, wherein: the shaft of the plunger plug includes afirst threaded portion, the plunger body includes a second threadedportion, and the first threaded portion of the shaft of the plunger plugis configured to engage the second threaded portion of the plunger bodyto removably couple the plunger plug to the plunger body.
 8. The plungerof claim 4, wherein the shaft further includes a plug stopper at itsdistal end.
 9. The plunger of claim 8, wherein: the plunger head isconfigured to be removably coupled to a plunger head stopper, and whenthe plunger head stopper is coupled to the plunger head, the plungerpassageway extends through the plunger head stopper to receive the plugstopper.
 10. The plunger of claim 9, wherein the plug stopper has asnap-fit connection with the plunger body.
 11. The plunger of claim 10,wherein: the plug stopper includes a rib, the plunger body defines agroove, and the rib of the plug stopper is configured to engage thegroove of the plunger body to snap-fit the plug stopper to the plungerbody.
 12. The plunger of claim 8, wherein the plug stopper comprises oneor more vents that are configured to allow air in the biomaterial toescape through the plunger passageway.
 13. The plunger of claim 4,wherein the shaft is configured to be coupled with an extension deviceto form the stylet when the shaft is decoupled from the cap.
 14. Theplunger of claim 4, wherein the plunger plug has a snap-fit connectionwith the plunger body.
 15. The plunger of claim 14, wherein: the shaftof the plunger plug includes a rib, the plunger body defines a groove,and the rib of the shaft is configured to engage the groove of theplunger body to snap-fit the plunger plug to the plunger body.
 16. Theplunger of claim 1, wherein the plunger head is sized to correspond withthe shape of the syringe passageway.
 17. The plunger of claim 16,wherein the shape of the plunger head and the shape of the syringepassageway are cylindrical.
 18. The plunger of claim 1, wherein theplunger passageway is centrally disposed within the plunger body. 19.The plunger of claim 1, wherein the plunger head comprises one or morevents that are configured to allow air in the biomaterial to escapethrough the plunger passageway.
 20. The plunger of claim 1, wherein thebiomaterial is bone graft material.